(115 days)
HC70TS
Not Found
No
The description focuses on the physical components and function of a hemoconcentrator, with no mention of AI or ML.
Yes
The device is intended for "the relief or mitigation of overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood," which directly aligns with the definition of a therapeutic device.
No
This device is a hemoconcentrator, used to remove fluid and concentrate blood components during cardiopulmonary procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical medical device (hemoconcentrator) made of polysulphone membranes, intended to be connected to an external cardiopulmonary blood circuit. It is not software.
Based on the provided information, the Bard® No-rinse Hemoconcentrator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "relief or mitigation of overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood." This describes a therapeutic intervention performed directly on the patient's blood within an external circuit, not a diagnostic test performed on a sample in vitro (outside the body).
- Device Description: The description details how the device is "Connected to the external cardiopulmonary blood circuit" and "generates ultrafiltrate." This confirms its use within a patient's blood circuit during a medical procedure.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample to diagnose a condition, monitor a disease, or determine a patient's health status. The device's function is to modify the composition of the blood itself.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The Bard Hemoconcentrator does not fit this description.
N/A
Intended Use / Indications for Use
The Bard® No-rinse Hemoconcentrator is intended for the relief or mitigation of overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.
Product codes
78 KDI
Device Description
The Bard No-rinse Hemoconcentrator and accessory kit for hemoconcentration serve the needs of cardiopulmonary procedures. Connected to the external cardiopulmonary blood circuit, the hemoconcentrator generates ultrafiltrate with electrolyte and solute compositions similar to that of plasma water.
The Bard' No-rinse Hemoconcentrators are made of glycerin-free polysulphone membranes. The no-rinse feature provides convenience of inserting the device into the external cardiopulmonary blood circuit without the need to rinse the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
To determine the adequacy of the HC40TS as a hemoconcentrator the following performance testing was done: Cell damage, protein analysis, sieving coefficient, dynamic prime volume, ultrafiltration rate, and pressure drop. Results of this testing indicate that the HC40TS performs in a manner that is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Fresenius Hemoflow F40 Capillary Dialyzer, Bard Hemoconcentrator with Tubing Set, HC70TS, Research Medical Hemoconcentrator, Biofilter™ 140
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”
0
Image /page/0/Picture/0 description: The image shows a combination of letters and numbers in a handwritten style. The top line features the text "K971180", while the bottom line reads "p.1/3". The text appears to be written with a thick marker or pen, giving it a bold and clear appearance.
Bard Vascular Systems Division C.R. Bard. Inc. 25 Computer Drive Haverhill, MA 01832 508-373-1000
JUL 2 4 1997
An ISO 9001 Registered Division
Image /page/0/Picture/4 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and connected, giving the word a solid, block-like appearance. The color of the letters is black, contrasting with the white background.
510(k) SUMMARY FOR THE BARD' NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT- HC40TS
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21CFR §807.92.
Submitter Information: I.
| Name: | Bard Vascular Systems Division, C.R. Bard Inc. |
|---|---|
| Address: | 25 Computer Drive, Haverhill, MA 01832 |
| Contact Person: | Sandra L. Perreand |
| Date Summary Prepared: | July 2, 1997 |
II. Device Name:
| Proprietary Name: | Bard® No-rinse Hemoconcentrator and Accessory Kit, HC40TS |
|---|---|
| Common or Usual Name: | Hemoconcentrator |
| Classification Name: | High Permeability dialyzer |
III. Predicate Device(s):
- Fresenius Hemoflow F40 Capillary Dialyzer 1)
- Bard Hemoconcentrator with Tubing Set, HC70TS 2)
- Research Medical Hemoconcentrator, Biofilter™ 140 3)
IV. Device Description:
The Bard No-rinse Hemoconcentrator and accessory kit for hemoconcentration serve the needs of cardiopulmonary procedures. Connected to the external cardiopulmonary blood circuit, the hemoconcentrator generates ultrafiltrate with electrolyte and solute compositions similar to that of plasma water.
The Bard' No-rinse Hemoconcentrators are made of glycerin-free polysulphone membranes. The no-rinse feature provides convenience of inserting the device into the external cardiopulmonary blood circuit without the need to rinse the device.
1
Pre-rinsed Hemoconcentrator:
| Unit Length: | 29.4 cm |
|---|---|
| Unit Diameter: | 2.8 cm |
| Membrane Surface Area: | 0.7m² |
| Blood Vol (Approx): | 42 ml |
| Hollow Fiber Material: | Polysulfone |
| Potting Material: | Polyurethane |
| Filter Housing: | Polycarbonate |
| Port Caps: | Polyethylene |
| Sterilization: | Ethylene Oxide |
| O-Ring: | Silicone |
| Max Transmembrane Pressure: | 600 mm Hg |
| Max Safe Blood Flow Rate: | 500 ml/min |
Accessory Kit
(
| ID | OD | Length | |
|---|---|---|---|
| Blood Inlet tubing | 1/4" | 3/8" | 36" |
| Blood Outlet tubing | 1/4" | 3/8" | 36" |
| Filtrate tubing | 1/4" | 3/8" | 36" |
| 1/4" Male Luer Adapter | 2 each | ||
| Tubing material: | Polyvinyl chloride |
V. Indications for Use:
The indications for use for the subject device and the three predicate device's are as follows:
| Indications | |
|---|---|
| Bard HC40TS | |
| hemoconcentrator | The Bard No-rinse Hemoconcentrator is intended for the relief or mitigation of |
| overhydration in patients undergoing cardiopulmonary procedures and to | |
| increase the concentration of cells and proteins in the blood. | |
| Bard HC70TS | |
| hemoconcentrator | The Bard HC70TS Hemoconcentrator with Tubing Set is intended for use as |
| an ultrafiltration system to remove excess fluid during and/or following | |
| cardiopulmonary bypass procedures where acute hemodilution has been | |
| employed. | |
| Research Medical | |
| Biofilter 140 | |
| hemoconcentrator | The RMI BioFilter Hemoconcentrator is intended for use as an ultrafiltration |
| device for the relief or mitigation of overhydration in patients undergoing | |
| cardiopulmonary bypass procedures and to decrease the concentration of | |
| plasma water in blood. | |
| Fresenius Hemoflow | |
| F40 hemodialyzer | Hemoflow dialyzer Series F (High-Flux) are designed for single use in acute |
| and chronic haemodialysis. |
While the Fresenius dialyzer is indicated for use during kidney dialysis and the Bard hemoconcentrator is indicated for use during cardiopulmonary bypass procedures both device function in the same manner. Both devices are intended to remove excessive fluid and solutes
2
from the patients blood. The only difference between the two uses is the procedure in which it's incorporated into, ie; dialysis vs. bypass procedures.
VI. Technological Characteristics:
The Bard HC40TS is identical in terms of design and materials to the Fresenius Hemoflow F40 hemodialyzer. As summary of the technological characteristics are as follows:
| | HC40TS Bard Hemoconcentrator | Fresenius Hemoflow F40
Hemoconcentrator |
|-----------------------|------------------------------|--------------------------------------------|
| Housing | Polycarbonate | Polycarbonate |
| Potting Compound | Polyurethane | Polyurethane |
| Capillaries | Polysulfone | Polysulfone |
| O-ring | Silicone | Silicone |
| Port Caps | Polyethylene | Polyethylene |
| Unit Length | 29.4 cm | 29.4 cm |
| Unit Diameter | 2.8 cm | 2.8 cm |
| Membrane Surface Area | 0.7 m2 | 0.7 m2 |
| Max TMP | 600 mmHg | 600 mmHg |
| Max blood flow | 500 ml/min | 300 ml/min |
| Priming volume | 42 ml | 42 ml |
VII. Performance testing
To determine the adequacy of the HC40TS as a hemoconcentrator the following performance testing was done: Cell damage, protein analysis, sieving coefficient, dynamic prime volume, ultrafiltration rate, and pressure drop. Results of this testing indicate that the HC40TS performs in a manner that is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure with three stylized stripes representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 4 1997
Ms. Sandra L. Perreand Regulatory Affairs Program Manager Bard Vascular Systems Division ....... C.R. Bard, Inc. 25 Computer Drive Haverhill, Massachusetts 01832
Re: K971180
Bard® No-Rinse Hemoconcentrator and Accessory Kit - HC40 and HC40TS .. . . Dated: July 2, 1997 Received: July 3, 1997 Regulatory class; III 21 CFR §876.5860/Product code: 78 KDI
Dear Ms. Perreand:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ATTACHMENT B
INDICATION STATEMENT
Device Name:
Bard" No-rinse Hemoconcentrator and Accessory Kit- HC40 and . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HC40TS
Indication for Use: The Bard® No-rinse Hemoconcentrator is intended for the relief or mitigation of overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.
Robert P. Setting/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 471180 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use
(Per 21 CFR 801.109)
Over-the-Counter Use_